Systems and methods for improved stability of electrochemical sensors

• US 8,932,445 B2
• Filed: 09/30/2010
• Issued: 01/13/2015
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Chatelier, Ronald C., Hodges, Alastair M.
• Primary Examiner(s): DINH, BACH T
• Application Number:
  US12/895,168
• Publication Number:
  US 20120080326A1
• Time in Patent Office: 1,566 Days
• Field of Search: 20440101-40315, 2057775-778, 205/792
• US Class Current: 204/403.01
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

Methods for determining a concentration of an analyte in a sample, and the devices and systems used in conjunction with the same, are provided herein. In one exemplary embodiment of a method for determining a concentration of an analyte in a sample, a sample including an analyte is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and a measurement of a parameter correlating to changes in a physical property of the sample analyzing device is calculated. A concentration of the analyte in view of the parameter correlating to a change in the physical property can then be determined Systems and devices that take advantage of the parameter correlating to changes in a physical property to make analyte concentration determinations are also provided.

Claims

1. A method for determining a concentration of an analyte in a sample, the method comprising:

introducing a sample including an analyte into an electrochemical cell of a sample analyzing device to cause a transformation of the analyte, the electrochemical cell having a first electrode and a second electrode;

determining a measurement of a parameter correlating to a physical property of the electrochemical cell, said parameter comprising a measured capacitance of the electrochemical cell;

calculating a correction factor, wherein said correction factor is in view of at least said parameter; and

determining a first analyte concentration and a corrected concentration of the analyte in view of the correction factor, wherein determining said measured capacitance of the electrochemical cell further comprises;

applying a first test voltage between the first electrode and the second electrode after the presence of sample has been detected in the test strip for a first time interval to determine whether sample or a control solution has been introduced into the test strip;

applying a second test voltage between the first electrode and the second electrode for a second time interval sufficient to oxidize a reduced mediator at the second electrode, the second test voltage having a higher absolute magnitude than that of the first test voltage, the second test voltage having an AC voltage component and a DC voltage component, the AC voltage component being applied at a predetermined amount of time after the application of the second test voltage, the DC voltage component having a magnitude to cause a limiting test current at the second electrode, the second electrode not having a reagent layer coating;

applying a third test voltage between the first electrode and the second electrode for a third time interval following the application of the second test voltage sufficient to oxidize a reduced mediator at the first electrode; and

processing a portion of the test currents, resulting from the AC voltage component, into a capacitance value,

and in which the first analyte concentration is calculated based on test current values during the second time interval and the third time interval and the corrected analyte concentration is calculated based on the first analyte concentration and the correction factor.

2. The method of claim 1, wherein said physical property is related to at least one of an age of electrochemical cell and a storage condition of the electrochemical cell.

3. The method of claim 2, wherein said storage condition comprises a storage temperature and a storage time.

4. The method of claim 1, wherein the sample analyzing device comprises a glucose sensor.

5. The method of claim 1, wherein the sample analyzing device comprises an immunosensor.

6. The method of claim 1, wherein the sample comprises blood.

7. The method of claim 6, wherein the blood comprises whole blood.

8. The method of claim 1, wherein the predetermined amount of time for applying the AC voltage component is equal to 0.3 to 0.4 seconds from application of the DC voltage component of the first test voltage.

9. The method of claim 1, wherein the predetermined amount of time for applying the AC voltage component is a time where a test current transient as a function of time is equal to zero.

10. The method of claim 1, wherein the predetermined amount of time is a time required for a peak current value to decay by about 50 percent.

11. A method for measuring a corrected analyte concentration, the method comprising:

applying a sample containing an analyte to a test strip;

applying to the sample a first test voltage for a first time interval between a first electrode and a second electrode after the presence of sample has been detected in the test strip to determine whether sample or a control solution has been introduced into the test strip;

applying to the sample a second test voltage for a second time interval between the first electrode and the second electrode sufficient to oxidize a reduced mediator at the second electrode and having a higher absolute magnitude than that of the first test voltage;

following the application of the second test voltage, applying to the sample a third test voltage for a third time interval between the first electrode and the second electrode sufficient to oxidize the reduced mediator at the first electrode;

calculating a first analyte concentration in the sample based on test current values during the second time interval and the third time interval;

determining a capacitance of the test strip; and

calculating a capacitance corrected analyte concentration based on the first analyte concentration and the capacitance wherein said determining a capacitance of the test strip further comprises;

applying the second test voltage between the first electrode and the second electrode, the second test voltage having an AC voltage component and a DC voltage component, the AC voltage component being applied at a predetermined amount of time after the application of the second test voltage, the DC voltage component having a magnitude sufficient to cause a limiting test current at the second electrode, the second electrode not having a reagent layer coating; and

processing a portion of the test currents, resulting from the AC voltage component, into a capacitance value.

12. The method of claim 11, wherein the step of calculating the capacitance corrected analyte concentration comprises:

calculating a correction factor based on the capacitance and the first analyte concentration, wherein the capacitance corrected analyte concentration is calculated based on the first analyte concentration and the correction factor.

13. The method of claim 12, wherein the step of calculating the capacitance corrected analyte concentration further comprises:

dividing the correction factor by one hundred and adding one to give an intermediate term; and

multiplying the intermediate term by the first analyte concentration to give a capacitance corrected analyte concentration.

14. The method of claim 12, further comprising:

determining if the correction factor is greater than a correction factor threshold value, then setting the correction factor to the correction factor threshold value.

15. The method of claim 12, wherein the correction factor is about zero when the capacitance is about equal to a predetermined ideal capacitance of the test strip.

16. The method of claim 11, wherein the capacitance corrected analyte concentration is calculated when the capacitance is less than a first capacitance threshold and the first analyte concentration is greater than a first analyte concentration threshold.

17. The method of claim 11, wherein the analyte comprises glucose.

18. The method of claim 11, wherein the predetermined amount of time for applying the AC voltage component is equal to 0.3 to 0.4 seconds from application of the DC voltage component of the second test voltage.

19. The method of claim 11, wherein the predetermined amount of time for applying the AC voltage component is a time where a test current transient as a function of time is equal to zero.

20. The method of claim 11, wherein the predetermined amount of time is a time required for a peak current value to decay by about 50 percent.